Value through Innovation27 July 2016

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Clinical Study Results

  • Volasertib - Ovarian Neoplasms
    Clinical Study Number 1230.18
    Study Indication Ovarian Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II
    Study Title

    Phase II randomized trial of the Polo-like kinase 1 inhibitor BI 6727 monotherapy versus investigator’s choice chemotherapy in ovarian cancer patients resistant or refractory to platinum-based cytotoxic therapy

    Study Document
    Trial synopsis 1230.18_DR english
  • Volasertib - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1230.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II
    Study Title

    A randomized open-label Phase II trial of BI 6727 monotherapy and BI 6727 in combination with standard dose pemetrexed compared to pemetrexed monotherapy in second line non-small cell lung cancer

    Study Document
    Trial synopsis 1230.5_DR english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.30
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label, Phase I, dose escalation trial to investigate the maximum tolerated dose, safety, pharmacokinetics, and efficacy of volasertib in combination with decitabine in patients >= 65 years with acute myeloid leukemia

    Study Document
    Trial statement 1230.30 english
    Trial synopsis 1230.30 english
    Lay summary 1230.30 english
  • Volasertib - Myelodysplastic Syndromes
    Clinical Study Number 1230.43
    Study Indication Myelodysplastic Syndromes
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label, phase I trial of intravenous administration of volasertib as monotherapy and in combination with azacitidine in patients with myelodysplastic syndrome after hypomethylating agents treatment failure

    Study Document
    Trial statement 1230.43 english
    Trial synopsis 1230.43 english
  • Volasertib - Myelodysplastic Syndromes
    Clinical Study Number 1230.33
    Study Indication Myelodysplastic Syndromes
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label Phase I dose escalation trial to investigate the maximum tolerated dose, safety, pharmacokinetics and efficacy of intravenous volasertib in combination with subcutaneous azacitidine in patients with previously untreated high-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell transplant

    Study Document
    Trial statement 1230.33 english
    Trial synopsis 1230.33 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.15
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open-label phase I study of once every three weeks intravenous treatment with BI 6727 in Japanese patients with advanced solid tumours

    Study Document
    Trial synopsis 1230.15 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.16
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    A Phase I single dose escalation study of two dosing schedules of BI 6727 administered intravenously in Asian patients with various solid cancers with repeated administration in patients with clinical benefit

    Study Document
    Trial synopsis 1230.16 english
  • Volasertib - Urologic Neoplasms
    Clinical Study Number 1230.2
    Study Indication Urologic Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II
    Study Title

    An open-label, single-arm, Phase II trial of intravenous volasertib (BI 6727) in patients with locally advanced, metastatic or recurrent urothelial cancer of the bladder, renal pelvis, or ureters after failure of prior chemotherapy

    Study Document
    Trial synopsis 1230.2 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.20
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label phase I dose escalation trial of intravenous BI 6727 in combination with oral BIBW 2992 in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document
    Trial synopsis 1230.20 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.23
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    Investigation of the metabolism, excretion and pharmacokinetics of an open-label single dose 300 mg (14C)volasertib administered intravenously in patients with various solid tumours with a possible extension phase with non-labelled drug

    Study Document
    Trial synopsis 1230.23 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.26
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label, phase I trial of intravenous once every 2 weeks administration of BI 6727 in Japanese patients with acute myeloid leukemia

    Study Document
    Trial synopsis 1230.26 english
  • Volasertib - Leukemia, Myelomonocytic, Chronic
    Clinical Study Number 1230.35
    Study Indication Leukemia, Myelomonocytic, Chronic
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label Phase I trial of intravenous volasertib in combination with subcutaneous azacitidine in Japanese patients with higher-risk myelodysplastic syndrome or chronic myelomonocytic leukemia

    Study Document
    Trial synopsis 1230.35 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.6
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    A phase I dose escalation trial of BI 6727 in combination with cisplatin or carboplatin in patients with advanced or metastatic solid tumours

    Study Document
    Trial synopsis 1230.6 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.7
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label phase I dose escalation trial of intravenous BI 6727 in combination with oral BIBF 1120 in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document
    Trial synopsis 1230.7 english
  • Volasertib - Neoplasms , Leukemia
    Clinical Study Number 1230.27
    Study Indication Neoplasms ; Leukemia
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    Open, non-controlled, dose-escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability, and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known

    Study Document
    Trial synopsis 1230.27 english
    Lay summary 1230.27 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.25
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II/III
    Study Title

    A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator’s choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

    Study Document
    Trial statement 1230.25 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.28
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    Open-label, dose-escalating trial to evaluate the tolerability, toxicity, safety, pharmacokinetics, pharmacodynamics and activity of volasertib added to the standard intensive salvage chemotherapy regimen with liposomal daunorubicine, fludarabine and cytarabine (DNX-FLA) followed by fludarabine and cytarabine (FLA) in children from 3 months to less than 18 years of age with acute myeloid leukaemia after failure of the front-line therapy

    Study Document
    Trial statement 1230.28 english

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